Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 29, 2019
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system w…
Neusoft Medical Systems Co., Ltd. recalled NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner Sys… - a moderate-severity action.
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner Sys… was recalled by Neusoft Medical Systems Co., Ltd. in May 29, 2019. Reason: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during …. Check the official notice for the remedy. Verify recall #Z-1280-2019 with the FDA Devices before acting.
The recall
Neusoft Medical Systems Co., Ltd. issued this moderate-severity FDA Devices recall-Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during ….
- Moderate
- severity level
- 6 units
- affected scope
- Class II
- classification
- May 29, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1280-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1280-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on October 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Neusoft Medical Systems Co., Ltd. is listed as the recalling firm, operating out of Shenyang, N/A. Federal records list the affected scope as 6.
The documented reason for this recall is: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of th… Distribution data in the federal record shows the product reached: US Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6
Related Recalls
6
6 from same agency
Product description
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Reason for recall
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1280-2019 |
| Date reported | May 29, 2019 |
| Date initiated | October 22, 2018 |
| Recalling firm | Neusoft Medical Systems Co., Ltd. |
| Firm location | Shenyang, N/A |
| Affected scope | 6 |
| Distribution | US Nationwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1280-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.. Recalled by Neusoft Medical Systems Co., Ltd.. Units affected: 6.
Why was this product recalled? ▼
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1280-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1280-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 40909 other recalls in this category.
FDA Devices Moderate
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mate…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathe…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical, Inc. · 2026-07-29
FDA Devices Moderate
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. · 2026-07-29
FDA Devices Moderate
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. · 2026-07-29
Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 29, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.